From CASAA:
FDA Deeming Regulations: Release and Next Steps
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Today, May 5th, 2016, the Food and Drug Administration (FDA) has announced the final rule on docket FDA-2014-N-0189 / RIN 0910-AG38 (otherwise known as the Deeming Rule). It is important for our members to understand what happens next.
The FDA has placed the rule in the Federal Register “Public Inspection File” pending publication in the Federal Register. This is everyone’s first chance to see the new rule. It will be officially published earliest on Tuesday, May 10th.
Please keep in mind that this is not the end of the process. CASAA will continue to focus our efforts to develop sensible regulation of vapor products that will have maximum benefit to consumers. The most important thing to remember is that consumers will continue to have access to the wide variety of vapor products for a period of time before the regulations take effect. But, for now, vaping as we know it will continue and we are not done by any means. Keep calm.
CASAA will be investing our collective time and experience over the next few days to review the new rule. This review is not like reading a novel, or even the technical manual for a starship. Federal regulations are written in what we euphemistically call “Reg Speak” — legal language that defines the actions of the rule. It isn’t easy to read because quite often sentences, paragraphs, and whole sections relate to other published documents, like the Family Smoking Prevention & Tobacco Control Act, and the Food, Drug, & Cosmetics Act. These laws require skill to read and determine what is being said. This is not a job for amateurs as it requires years of practice; no single person is likely to get it right all by themselves.
CASAA is urging our members to be patient and remember that nothing in the rule will affect you tomorrow, next week, or even next month. The FDA will take time to actually implement the new rule. Please bear with all of us. We will be working diligently to provide accurate information and analysis just as fast as possible.
The most important thing you can do is to make a call, write, or send an email to your Representative and urge them to cosponsor and support HR 2058. If there is one thing that has to be done, this is it. Encourage your family members, friends, everyone who has supported your journey to participate.
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Here are the documents we will be reviewing:
- FInal Deeming Rule: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf
- Proposed Rule: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10687.pdf
We will update this post as we move through our review of the published regulations.
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